Virtualization provides the flexibility to easily add and remove workstations, which is especially important in development or training systems where you may frequently need to set-up and tear down systems. Virtualization also makes it easy to support multiple systems, on multiple software releases, with the same virtualization hardware.
Software applications store and manage data electronically for each batch produced including the entire manufacturing process on a step-bystep basis. EBR software systematically generates a formal master batch record or EBR. This master record stores all the materials, processes and activities which were required to produce a given product. Electronic batch records provide the structure and means for automatically compiling batch production data into a formatted electronic document, reducing paper and manual records for more accurate record keeping. Data is recorded and stored in encrypted form, guaranteeing data privacy and security. This should lead to quicker release of the product to the marketplace.
Many modern facilities are focused on good alarm management practices for the purpose of avoiding alarm floods and prevention of unsafe situations occurring where an operator cannot clearly see the root cause of the alarm. There are systematic approaches towards alarm management on new greenfield projects and also proven approaches to remedy poor alarm management at existing facilities.
Our partners at the IAAE have been awarded a project by MxD on behalf of the FDA Office of Counterterrorism and Emerging Threats to identify the barriers and benefits to adoption of smart manufacturing technology in the medical product manufacturing industry.